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ENGLISH

Table of Contents

Design Philosophy .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 3
Function   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 3
Product Description   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4
User Profile .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4
Intended Use/Indications  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4
Performance Characteristics  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4
Contraindications   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4
Warnings And Precautions    .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 5
Latex Information   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 6
Contents  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  6

General System Information and Application

Pump Features   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 7
Symbol Definitions   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 8
Pump Set-up   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 9
Cuff Application  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 10
Pump Operation .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 11
Single Leg Operation   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 11
Patient Compliance Counter Reset   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 11

System Alarms

Alarm Reset   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 12
S Mode Operation  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 12
Tube Alarm .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 13
Enabling Compliance Alarm   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 13
Compliance Alarm .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 13
Call For Service Alarm .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 13

Battery Information and Operation

Battery Operation   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 14
Battery Charging Instructions  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 14
Lithium Iron Phosphate Battery Maintenance Guidelines .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 14
Battery Maintenance   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 15
Storage   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 15
Handling Precautions .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 15
Low Battery Alarm .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 16

Replacement Kit Instructions

Instructions for Installing/Removing/Replacing the Power Cord  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 17
Telescoping Bed Hanger Replacement   .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 17
Instructions for Replacing Fuses .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 17

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Summary of Contents for 30BI-S

Page 1: ...peration 11 Patient Compliance Counter Reset 11 System Alarms Alarm Reset 12 S Mode Operation 12 Tube Alarm 13 Enabling Compliance Alarm 13 Compliance Alarm 13 Call For Service Alarm 13 Battery Information and Operation Battery Operation 14 Battery Charging Instructions 14 Lithium Iron Phosphate Battery Maintenance Guidelines 14 Battery Maintenance 15 Storage 15 Handling Precautions 15 Low Battery...

Page 2: ...tibility EMC Tables RF Emissions Class A Guidance and Manufacturer s Declaration Electromagnetic Emissions 23 Guidance and Manufacturer s Declaration Electromagnetic Immunity 24 Guidance and Manufacturer s Declaration Electromagnetic Immunity 25 Recommended separation distances between portable and mobile RF communications equipment and the VenaFlow Elite 26 Specifications Classifications 27 Stora...

Page 3: ...lite system begins the compression cycle and inflates the cuffs one leg at a time alternating between the two legs every 30 seconds First the distal aircell inflates rapidly within less than 0 5 seconds then the proximal aircell follows Foot Cuffs The pressure peaks at approximately 130mmHg 10 Calf Cuffs The distal pressure peaks at approximately 73mmHg 15 and the proximal pressure peaks at approx...

Page 4: ...ells contained in the cuff via the connector tubing User Profile The intended user should be a licensed medical professional The user should be able to read and understand the operator s manual warnings and cautions manually apply the compression cuffs sense auditory and visual signals Intended Use Indications The VenaFlow Elite S Mode System is intended as a prophylaxis for deep vein thrombosis D...

Page 5: ...dio frequency energy and if not installed and used in accordance with instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation Harmful interference to other devices can be determined by turning this equipment on and off Try to correct the interference using one or more of the following R...

Page 6: ...comfort compliance and skin irritation Special attention should be given to those patients with neuropathies or tissue viability problems i e diabetes arterial or venous insufficiencies To prevent extremity compartment syndrome special attention should be given to patients who are positioned in the supine lithotomy position for extended lengths of time This includes patients with or without compre...

Page 7: ...eg operation 3 Patient compliance counter Displays treatment time in hours minutes and seconds 4 Patient compliance counter reset push button Resets the patient compliance counter 5 S Mode operation indicator 6 Single Dual Leg operation indicator Indicates single leg or dual leg operation is active 7 Battery indicator Indicates battery charge 8 S Mode operation button 9 ON OFF RESET push button Tu...

Page 8: ...peration Lock mode CE Mark of conformity with notified body number Catalogue number Refer to Instruction Manual Booklet Keep dry Fragile handle with care This end up Temperature range Humidity range Atmospheric pressure range Federal Law restricts this unit to sale by or on the order of a physician or licensed practioner Authorized repesentative in the European Community Manufacturer Date of Manuf...

Page 9: ...r or table To use the telescoping bed hanger press release button on the back of the device and gently pull out bed hook to the desired width 2 Connect tube assembly to the pump Make sure tubing connectors lock securely into pump connectors 3 Plug in the power cord to electrical outlet ...

Page 10: ...ered on bottom of foot and with the tube pointed to the left Foot cuffs are only for use in standard rapid inflation mode Thigh cuff Apply cuff with the distal and proximal aircells centered on either the back side or front of the calf and thigh with the tube pointed toward the foot It doesn t matter where the aircell sits on the leg It will perform the same 2 Connect cuffs to the tubing that is a...

Page 11: ...ss The graphical display green pump indicator lights and green light above button will turn off 5 To shut down the power completely disconnect the power plug by removing it from the AC socket Single Leg Operation 1 Cuffs should be attached prior to powering on the device Once powered on the device will automatically detect if one or two cuffs are attached 2 Any changes to cuff configuration requir...

Page 12: ...in Standard Rapid or S Mode You have the ability to lock the system in either standard rapid mode or S mode Once a mode is locked it will stay in that mode regardless of powering the device on or off Once locked it is not possible to toggle modes until the system is unlocked To lock the system in standard rapid inflation mode First make sure the device is in standard rapid inflation mode The S mod...

Page 13: ...der Done to set the new configuration The change is complete and the system is ready to operate A C will appear on the display indicating that the compliance alarm is enabled Compliance Alarm 1 If the cuffs are removed from the patient while the device is still functioning and the cuffs are not reapplied after 15 minutes the system will go into alarm mode and the graphical display will read COMPLI...

Page 14: ...the battery when the unit is off When the unit is on it takes an estimated 2 hours to charge the battery Lithium Iron Phosphate Battery Maintenance Guidelines Overview Do not leave batteries unused for extended periods of time because Lithium Iron Phosphate batteries continue to slowly discharge self discharge when not in use or while in storage Routinely check the battery s charge status The prod...

Page 15: ...s The battery is best stored at 23 5 C For periods of less than 1 month the battery can be stored between 25 C to 70 C NOTE The battery self discharges during storage Higher temperatures above 20 C or 68 F reduce the battery storage life Handling Precautions Do not disassemble crush or puncture a battery Do not short the external contacts on a battery Do not dispose of a battery in fire or water D...

Page 16: ...nate with the text LOW BATTERY When there is approximately 5 minutes left two 10 second beeps will sound per minute in addition to the graphical alert 2 When either battery alarm occurs immediately plug device in to electrical outlet to begin replenishing the charge 3 If the device is not plugged in during the alarm period the device will shut down and will fail to power on again until the device ...

Page 17: ... can be removed and replaced if necessary 2 To replace the bed hanger hold down release button on the back of the system and firmly pull bed hanger out of the body of the system 3 Discard the broken or ineffective hanger To install the new bed hanger slide the new hanger back into the body of the device and set at desired length Instructions for Replacing Fuses 1 Remove the power cord Refer to the...

Page 18: ...ng Dimethyl benzyl ammonium chloride or Dimethyl ethylbenzyl ammonium cloride Tec Surf II or solutions containing chlorine Maintenance Prior to each use inspect the device power cord cuff and tubing for damage If damage is detected contact Customer Service See Customer Care Contact Information section NOTE The unit was tested during the manufacturing process and is ready to be placed into service ...

Page 19: ... cuffs tube units and battery packs for material or workmanship defects not including normal depreciation of battery life or charge capacity for a period of six months from the date of sale Optional Tube Alarm Verification Test The Tube Alarm Verification Test is provided for facility verification purposes only and is not required prior to use Attach tube assembly to pump and connect power cord to...

Page 20: ... VenaFlow Elite Bariatric Calf Cuff Pair 76 cm 30 in 3045 VenaFlow Elite Thigh Cuff Pair One size fits all 3046 VenaFlow Elite Foot Cuff Pair One size fits all 3050 VenaFlow Elite Foam Calf Cuff Pair 48 cm 19 in 3008 Tube Assembly 167 64 cm 66 in Each 3008XL Tube Assembly 259 08 cm 102 in Each 3008XXL Tube Assembly 320 04 cm 126 in Each 3008XXXL Tube Assembly 381 cm 150 in Each System Replacement ...

Page 21: ...frica English 220 V 50 Hz BS546 3052 Malaysia English Malay 240 V 50 Hz BS1363 BS546 3048 3052 Thailand English Thai 220 V 50 Hz CEE7 7 UL NEMA5 15 250V 3049 3047 Greece Greek 230 V 50 Hz CEE7 7 3049 Hong Kong English 220 V 50 Hz BS1363 BS546 3048 3052 India English 230 V 50 Hz BS546 3052 Jordan English Arabic 230 V 50 Hz UL NEMA5 15 250 V BS1363 CEE7 7 BS546 3047 3048 3049 3052 Turkey Turkish 230...

Page 22: ...g to operate or other incorrect functioning If this occurs survey the site of disruption and take the following actions to eliminate the source s Turn equipment in the vicinity off and on to isolate disruptive equipment Relocate or reorient interfering equipment Increase distance between interfering equipment and your system Manage use of frequencies close to the system frequencies Remove devices ...

Page 23: ...omagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The VenaFlow Elite uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The VenaFlow Elite is suitable for use in all establishments other than domestic and those directly connected to the public low ...

Page 24: ...l mode 2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle ...

Page 25: ...urvey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflect...

Page 26: ...mitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d 80 MHz to 800 MHz d 800 MHz to 2 5 GHz d 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the tr...

Page 27: ...ePO4 12 8V 1500 mAh Fuse F2AL250V Quantity 2 Classifications Degree of Protection from Electrical Shock Class 1 Type BF Applied parts Cuffs IPX0 Ordinary protection No sterilization is required This device is not intended for use in an Oxygen Rich Environment Mode of operation is Continuous Operation Storage Transportation Conditions Temperatures 13 F 25 C 158 F 70 C Relative Humidity 15 93 Atmosp...

Page 28: ...hina A312 SOHO ZhongShan Plaza 1055 W ZhongShan Rd Shanghai 200051 CHINA Tel 8621 6031 9989 Fax 8621 6031 9709 Email information_china DJOglobal com DENMARK FINLAND NORWAY SWEDEN DJO Nordic AB Murmansgatan 126 21225 Malmö SWEDEN Tel Sweden 040 39 40 00 Tel Norway 8006 1052 Tel Finland 0800 114 582 Tel Denmark 46 40 39 40 00 Email info nordic DJOglobal com FRANCE DJO France S A S Centre Européen de...

Page 29: ... Fax 39 02 484 09217 Email vendite DJOglobal com SOUTH AFRICA DJO South Africa Pty Ltd Unit 1 Brackengate Business Park 5 on London Brackenfell 7560 Cape Town SOUTH AFRICA Tel 27 0 87 3102480 Fax 27 0 86 6098891 Email info southafrica DJOglobal com SPAIN DJO Ibérica Carretera de Cornellá 144 1º 4ª Esplugues de Llobregat 08950 Barcelona SPAIN Tel 34 943 638 167 Fax 34 943 638 174 Email svc cial DJO...

Page 30: ...NG KONG Tel 852 3105 2237 Fax 852 3105 1444 Email info asia bs DJOglobal com EUROPE MIDDLE EAST AFRICA EXPORT DJO Benelux Welvaartstraat 8 2200 Herentals BELGIUM Tel 32 0 14248350 Fax 32 0 14248358 Email info emea DJOglobal com LATIN AMERICA DJO LLC 1430 Decision Street Vista CA 92081 8553 U S A Tel 1 800 494 3395 Email info latam DJOglobal com ...

Page 31: ......

Page 32: ...30B120 REV F 2021 03 17 MDSS GmbH Schiffgraben 41 30175 Hannover Germany DJO LLC 1430 Decision Street Vista CA 92081 8533 USA ...

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